A new nationwide recall has been issued for a generic version of the heartburn and ulcer drug Zantac due to the potential presence of an impurity that could cause cancer. It’s the fourth recall for Ranitidine this month and the tenth since the initial recall in late September.
Golden State Medical Supply (GSMS) is recalling all quantities and lots of Ranitidine HCl 150mg and 300mg Capsules within certain expiration dates because of the potential presence of N-Nitrosodimethylamine (NDMA) that are above levels established by the FDA.
NDMA is a nitrosamine. The FDA says nitrosamines can be found naturally in water, meats, dairy products and vegetables, but NDMA is also a probable human carcinogen.
The November 6 recall by GSMS is based on a manufacturer’s recall by Novitium Pharma that was issued October 25. GSMS says it has not received any reports of adverse events related to the recalled products.
The recalled capsules are:
- Ranitidine Hydrochloride 150mg Capsules: Caramel colored capsules, imprinted 001 on cap and novitium 150 mg on body in white ink, filled with white to pale yellow powder.
- Ranitidine Hydrochloride 300mg Capsules: Caramel colored capsules, imprinted 002 on cap and novitium 300 mg on body in white ink, filled with white to pale yellow powder.
The lot numbers and expiration dates affected by the recall can be found on the FDA website at this link.
Consumers are urged to first talk to a doctor or pharmacist about alternatives before discontinuing use, the company said. Once an alternative is found, customers are urged to contact Novitium‘s recall processor — Stericycle Return Management Services — for instructions on returning the remaining capsules. Stericycle can be contacted at (866) 382-8606 or at Novitiumpharma6639@stericycle.com.
The FDA released a statement Nov. 1 that states its testing has found levels of NDMA in ranitidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” But, the agency says it still must test ranitidine in the human body to fully understand if it forms NDMA.let’s go.
The same impurity is one of three nitrosamines that have been found in some blood pressure medications, leading to dozens of recalls since July 2018.